Specimen Collection Procedures

Transcription

1 Specimen Collection Procedures I. Overview The following are the procedures for collecting urine and blood samples from participants in the VADA program. If the precise method of sample collection varies from these procedures in some circumstances, it does not serve to invalidate the collection or testing; however, minimum standards shall apply to ensure that the integrity of the sample is maintained throughout the collection and transportation process. II. Notification Athletes participating in the VADA program are required to provide up-to-date whereabouts information at all times during there participation as directed by VADA s Whereabouts Policy. This includes the Athlete s physical location, contact information, and a specific 60-minute time slot between 6 a.m. and 11 p.m. local time each day where the Athlete will be available for testing. Refer to VADA s Whereabouts policy for more detail. VADA will provide the Athlete s whereabouts information and collection instructions to the sample collection organization that is supplying the Doping Control Officer (DCO) who will oversee the sample collection on-site. These procedures begin with the arrival of a DCO at the specified collection location, and end with the dispatch of the urine and blood samples to the laboratory. III. Responsibilities A. The DCO shall be responsible for: Directing any other collection personnel at the collection location; Assessing and organizing the equipment, documents and facilities; Answering any questions about the process for sample collection; Witnessing, or arranging the proper witnessing of, sample provision; Coordinating the collection of a blood sample, if appropriate; Verifying the completeness and accuracy of the relevant paperwork and chain of custody; Arranging proper transport to the laboratory chosen by VADA. B. The Athlete shall be responsible for: Being available to provide urine and/or blood samples during the specified time at the specified location; 1

2 Being familiar with the sample collection process; Any food or beverage consumed prior to providing a sample; Maintaining the integrity of his/her own urine samples from provision to final sealing; Observing the procedure to ensure that there are no irregularities; Making any comments about the sample collection procedure on the documentation provided during the collection, if applicable; Declaring the use of any medication as specified on the collection documentation; Providing any TUE documentation to VADA, if applicable, prior to Sample provision; and Signing the doping collection documentation, as directed by the DCO. C. A VADA Athlete may request the presence of one Athlete Representative, if desired, who may accompany the Athlete to the doping collection location. The Athlete Representative should be familiar with the collection process and may act as an observer on behalf of the Athlete in the selection of equipment, completion of paperwork, and monitoring the collection process to ensure there are no irregularities. The Athlete Representative shall sign documentation as requested by the DCO. IV. Arrival of the DCO at the Collection Site A. The DCO shall identify him/herself and shall produce for the Athlete authorization documentation evidencing that he/she has been directed by VADA to collect the Athlete s blood and/or urine samples. DCO identification documents shall include name, photograph, and the documents expiration date. B. It is the DCO s responsibility to ensure that the Athlete is the first person notified that he/she has been selected for Sample collection. The following instances are examples of times where there may there be an exception to this: Where the Athlete is a minor, has a disability, or where an interpreter is needed and the DCO considers it a requirement to notify a third party prior to the notification of the Athlete; and Where the DCO requires assistance in locating, identifying and/or notifying the Athlete(s). C. The DCO shall, at a minimum, verbally confirm the Athlete s identity. If the Athlete is carrying photo ID, this may be checked at this stage. An Athlete s inability to provide photo ID shall not invalidate a test. D. The DCO should present the Athlete with the doping control form(s), and shall then notify the Athlete of the following: That the Athlete is required to undergo a urine and/or blood sample collection for VADA; That the Athlete may be subject to removal from the VADA program for failure to comply with the sample collection process; 2

3 The requirement for the Athlete to provide their sample in direct observation of a DCO or other collections personnel; The Athlete s rights, including the right to: o Have an Athlete Representative present throughout the course of the entire sample collection process (other than sample provision) and if available, an interpreter; o Ask for additional information about the sample collection process; o Request a short delay in beginning the sample collection process for valid reasons (see Section H, below, for what constitutes valid reasons). The Athlete s responsibilities, including the requirement to: o Remain within direct observation of the DCO at all times until the completion of the sample collection process; o Produce appropriate and valid identification as required; o Comply with the Sample collection procedures; o Report immediately for the collections process, unless there are valid reasons for a delay, as determined by the DCO. The location of the Doping Control Station; That should the Athlete choose to consume food or fluids prior to providing a sample, he/she does so at his/her own risk, and should in any event avoid excessive rehydration, having in mind the requirement to produce a sample with a suitable specific gravity for analysis; That the urine Sample provided by the Athlete to the sample collection personnel should be the first urine passed by the Athlete subsequent to the DCO s arrival. E. The DCO should encourage the presence of a third party during the notification process where the Athlete is a minor, it is required by an Athlete s disability or in situations where an interpreter is required. F. If an Athlete is not located based on available information, the DCO may attempt to locate the Athlete by other means, such as attempting to contact the athlete by telephone. The DCO should notify VADA for further instructions if the Athlete is not located. G. The Athlete shall read and sign the doping control form(s) as directed by the DCO. If any Athlete copies of the forms exist, they will be given to the Athlete. H. The DCO may at their discretion consider any reasonable request by the Athlete for permission to delay the sample collection process; and/or to leave the location of the sample collection temporarily after arrival. Such permission shall only be granted if the Athlete can be continuously chaperoned and kept under direct observation during the delay and if the request relates to the following activities: Locating an Athlete Representative; Completing a training session; Receiving necessary medical treatment; Obtaining photo identification; 3

4 Any other exceptional circumstances which may be justified, and which shall be documented by the DCO. I. The DCO shall document any reasons for delay in beginning the sample collection process and/or reasons for leaving the location of the sample collection that may require further investigation by VADA. Any failure of the Athlete to remain under constant observation, unusual Athlete behavior, or shall also be recorded. V. Preparation for the Urine Sample Collection Session A. The Athlete shall be provided with the opportunity to hydrate. If the Athlete is providing a blood sample at the same session, the DCO may request that the Athlete provide the blood sample first. Once the DCO has arrived at the collection site, the Athlete must be under observation at all times until sample collection is completed. The Athlete may request to leave the specimen collection location for a short time, for reasons listed above in section IV(H). The length of time shall be at the discretion of the DCO, depending on the particular circumstances. The Athlete must be escorted continuously at such times, and the purpose of leaving, agreed time of return, and actual time of return shall be documented by the DCO. If an Athlete insists on leaving the site without the DCO s approval, the circumstances shall be documented by the DCO. B. Before Sample collection, the DCO should ask the Athlete whether he/she has been tested before, and whether he/she requires an explanation of the collection procedure. If the Athlete has not been tested before, or requests an explanation of the procedure, the DCO should explain the sample collection procedure to the Athlete. C. The DCO shall ensure equipment and supplies are adequate for the Sample Collection Session. The type of equipment may vary but, as a guideline, the following equipment should be brought by the DCO to the sample collection site: Sealed, sterile urine collection vessels; Partial Sample kits; Equipment for measuring specific gravity; Sealed, tamper-evident containers for A and B Samples; Transport containers (if applicable); Secure courier transport bags; Disposable gloves; Soap or hand wash; Paper towels; Garbage bag or similar for disposal; All doping control documentation, including doping control forms, chain of custody forms, DCO Report Forms, etc. Sufficient sample collection equipment shall be brought by the DCO to ensure that at all times an Athlete selected for Testing has a choice of at least three Sample collection vessels, Sample collection kits and partial Sample kits. 4

5 D. Sample collection equipment systems used shall meet the following minimum criteria: Have unique numbering systems incorporated into all bottles, containers or other item used to seal the sample vessel; Have a sealing system that is tamper evident; Ensure the identity of the Athlete is not evident from the equipment itself; Ensure that all equipment is clean and sealed prior to use by the Athlete. E. The DCO shall assess the facilities and find a specific location that shall afford the Athlete privacy. The collection site may be an Athlete s home, hotel room, training facility, or any other designated site. The DCO shall determine the most appropriate specific location at the site to hold the sample collection session. 1. Access to the Doping Control Station is restricted to the Athlete, any Athlete Representative, an interpreter if required, and any sample collection personnel, unless otherwise agreed by the DCO. 2. The DCO may wish to assign a member of the sample collection personnel to monitor access to the Doping Control Station, and ensure that only authorized persons are admitted. F. The DCO shall brief any sample collection personnel on their roles and responsibilities prior to the sample collection process. VI. Conducting the Urine Sample Collection Session A. Selection of the Sample collection vessel 1. The Athlete shall be given a choice of Sample collection vessels, from which they will be asked to choose one. It is recommended that the DCO bring at least three Sample collection vessels from which to choose. 2. The Athlete shall check that the equipment is clean and intact. If the Athlete is not satisfied with the equipment, they should make another selection. 3. If the Athlete is not satisfied with any of the equipment, and the DCO does not agree with the Athlete s opinion that all of the available equipment is unsatisfactory, the DCO shall instruct the Athlete to proceed with the sample collection session and the Athlete s views must be recorded on the doping control documentation by the DCO. 4. If both the DCO and the Athlete agree that none of the equipment is satisfactory, the DCO shall terminate sample collection, and record the reasons. 5. From this point, the sample collection vessel shall be handled only by the Athlete unless the Athlete authorizes the DCO to handle the vessel on his/her behalf. Such authorization must be documented. B. Providing the Urine Sample 1. The Witness (DCO or other collection personnel) shall escort the Athlete to the toilet facility. The Athlete will carry his/her own Sample collection vessel. If an Athlete Representative is present, the Athlete Representative may not accompany the Athlete and Witness into the toilet facility. 2. The Witness shall be of the same gender as the Athlete providing the sample. 5

6 3. Where practicable, the DCO should ensure the Athlete thoroughly washes his/her hands before providing a sample. 4. Once in the toilet facility the Athlete must remove all clothing between the waist and mid-thigh, in order that the Witness has an unobstructed view of sample provision. Sleeves should be rolled up so that the Athlete s arms and hands are also clearly visible. 5. The Witness shall directly observe the Athlete provide the urine sample, adjusting his/her position so as to have a clear view of the urine leaving the Athlete s body. 6. The DCO shall verify, in full view of the Athlete, that a suitable volume of urine has been provided. 7. Once a urine sample of at least 90mL has been collected, or the Athlete has provided a partial sample and is unable to provide any more urine at this time, the Witness shall escort the Athlete, who shall carry his/her own sample, back to an administration area designated by the DCO. The Athlete should be encouraged to provide as much volume as possible and the DCO should note where an Athlete makes attempts to provide only the bare minimum. 8. If an Athlete wishes to wash his/her hands after passing the sample, the sample shall at this time be placed in a safe and secure location, in full view of both the Athlete and the Witness. 9. If the Witness observes any unusual behavior by the Athlete while witnessing the passing of the sample, this shall be documented by the DCO. 10. The Witness shall sign the relevant documentation to verify that he/she witnessed sample provision in accordance with procedures. C. Insufficient Volume 1. In the event that an Athlete is unable to provide 90 ml of urine, the DCO shall follow the procedure for a partial sample. 2. The DCO shall advise the Athlete that the partial sample provided shall be secured and a further sample collected. 3. The DCO shall instruct the Athlete to select partial sample collection equipment, as per section A. 4. The DCO shall then instruct the Athlete to open the relevant equipment, pour the insufficient sample into the container, and seal it as directed by the DCO. The DCO shall check, in full view of the Athlete, that the container has been properly sealed. 5. The DCO and the Athlete shall check that the equipment code number and the volume and identity of the insufficient Sample are recorded accurately by the DCO. The Athlete and DCO may initial or sign the documentation to show they are satisfied with the procedure. 6. The Athlete shall remain under observation until ready to provide a further sample. 7. Either the Athlete or the DCO shall retain control of the sample. If the DCO takes control of the Sample, the DCO shall ensure that the sealed partial Sample is securely stored (under continuous observation or locked away in a secure area). If the Athlete retains possession of the Sample, it must be placed in a secure area, and must remain under the observation of sample collection personnel. 6

7 8. When the Athlete is ready to provide more urine, the sample provision process shall recommence. 9. To ensure continuity of the process, and for the comfort of the Athlete, the Witness should be the same Witness as for the initial attempt, whenever possible. However, a change of Witness shall in no way affect the integrity of the process. 10. The Athlete shall select a new Sample collection vessel, and repeat the process. This process shall be repeated until the DCO is satisfied that the Athlete has provided the required volume of urine once the initial and additional samples are combined. 11. The DCO shall ask the Athlete to inspect their partial Sample(s) to ensure that the seals are secure. Any irregularities shall be recorded by the DCO on the doping control documentation or in a separate report to VADA. 12. The DCO shall then direct the Athlete to break the seal of the partial sample container(s) and combine the Samples in a new collection vessel, beginning with the first partial Sample provided and each subsequent partial Sample until the desired volume is reached. 13. Once a minimum of 90 ml of urine has been collected, the DCO and Athlete shall proceed to the next stage. D. Dividing and sealing the Sample 1. The Athlete shall select, from a choice of urine kits, a kit consisting of A and B containers, in which the Sample is to be sealed. It is recommended that there are at least three urine kits from which to choose. 2. The Athlete and DCO should check that the urine kit is clean and intact. If neither the Athlete nor the DCO is satisfied with the urine kit(s), the Athlete shall make another selection. 3. If the Athlete is not satisfied with any of the urine kits, and the DCO does not agree with the Athlete s opinion that all of the available urine kits are unsatisfactory, the DCO shall instruct the Athlete to proceed with the sample collection session, and the Athlete s views must be recorded on the doping control documentation by the DCO. 4. If both the DCO and the Athlete agree that none of the urine kits are satisfactory, the DCO shall terminate the session, and record the reasons. 5. The Athlete and the DCO shall check the urine kit to ensure that all the numbers of the A and B containers correspond. 6. If the numbers do not correspond, the DCO shall instruct the Athlete to select another kit. The DCO shall document this. 7. The DCO shall record the urine kit numbers and the Athlete and the DCO shall check the documentation to ensure that the DCO has accurately recorded the numbers of the A and B containers. 8. The Athlete shall pour approximately 30 ml of urine into the B container. 9. The Athlete shall pour the remainder of the urine into the A container. If the A container is filled to capacity the Athlete shall then pour any remaining urine into the B container, leaving a residual amount of urine in the collection vessel. 10. The DCO shall instruct the Athlete in the sealing of the A and B containers. Both the DCO and the Athlete shall check that the bottles are securely sealed. 7

8 11. The DCO shall confirm that the sample meets the requirements for analysis, by testing the residual volume of urine remaining in the collection vessel for specific gravity (greater than or equal to if using a refractometer, or with lab sticks). Reagent strips and/or a refractometer may be used. 12. The DCO shall ensure that any residual urine that will not be sent for analysis is discarded in full view of the Athlete. E. Samples not meeting laboratory guidelines for analysis 1. If the reading is outside the required range for specific gravity the DCO shall request collection of additional sample(s). 2. Additional samples shall be collected until the Athlete has provided a sample within the required range for specific gravity, unless exceptional circumstances prevail. 3. While waiting to provide an additional sample the Athlete shall remain under continuous observation by doping collection personnel. 4. The Athlete shall be encouraged not to hydrate excessively, since this may delay the production of a suitable sample. 5. When the Athlete is able to provide an additional sample, the DCO shall repeat the above procedures for collection of the sample. 6. Whenever possible, provision of additional samples should be observed by the same Witness as for the first. However, a change of Witness shall not invalidate the Sample collection procedure. 7. The Witness shall sign the relevant documentation to verify that he/she witnessed sample provision in accordance with procedures. 8. The DCO should ensure that samples provided by the same Athlete can be linked through the documentation and that the laboratory is informed which the initial sample is. All samples shall be sent to the laboratory for analysis with all related paperwork. F. Paperwork 1. If the Athlete provided more than one sample and the Witness was not the same individual that witnessed provision of the first sample, all Witnesses shall sign the doping control form. 2. If the Witness is unable to verify that he/she observed the passing of the sample, or reports unusual behavior by the Athlete, the DCO can require the Athlete to provide a further sample. This must be documented, and all samples collected sent to the laboratory for analysis. 3. The DCO shall request the Athlete to provide information on all medications and/or supplements taken within the time period specified on the doping control form. 4. The DCO should check all information on the form and fill in any incomplete areas in view of the Athlete. The Witness then signs to confirm that the sample collection was conducted in accordance with procedures. 5. The Athlete should be invited to check that all information on the form accurately reflects the details of the sample collection session. The Athlete shall be invited to complete the comments section of the form if he/she has any concerns or comments regarding the procedure. If there is insufficient space on the form, the Athlete should be invited to complete a supplementary report form. 8

9 6. The Athlete s Representative, if present shall sign the Doping Control Form. 7. The Athlete and DCO shall then sign the Doping Control Form. 8. The DCO should give a full copy of the form to the Athlete. G. Sample Storage 1. The DCO has the responsibility for ensuring that all samples are stored in a manner that protects their identity, integrity and security at all times before the samples are handed over to a laboratory or courier. Samples must not be left unattended, unless they are locked away in a refrigerator or cupboard, for example. Access should be restricted to authorized personnel. 2. Where possible, samples should be stored in a cool environment. Warm conditions should be avoided. 3. The DCO shall accurately complete appropriate documentation for each transport bag/container to ensure that the laboratory can verify the contents of the bag/container. 4. The DCO shall follow VADA s instructions to ensure that, where required, instructions for the type of analysis to be conducted are provided to the laboratory. 5. The DCO shall complete the laboratory advice form/chain of custody form. The laboratory copy of this form(s) and the laboratory copy of the doping control form should be placed in the transport bag with the Samples. Documentation identifying the Athlete shall not be included with the Samples. VII. Blood Sample Collection Session Procedures A. Safety: When collecting blood for doping control purposes, the protection of the Athlete and sample collection personnel is paramount. The process must be carried out by experienced professionals who possess qualifications in phlebotomy recognized by the relevant public authorities, and the highest standards of hygiene and safety must be maintained at all times. The Blood Collection Officer (BCO) must have experience collecting blood samples and properly disposing of blood collection equipment. Where possible, the BCO should also be able to carry out first aid on the Athlete if required. B. Preparation for the Blood Sample Collection Session Procedures involving blood shall be consistent with relevant principles of internationally recognized standard precautions in health care settings. C. Preparation of the necessary equipment 1. The DCO shall ensure that equipment and supplies are adequate for the Blood Sample Collection Session. The type of equipment may vary but, as a guideline, the following should be made available: Sterile needles Butterfly Needles Disposable plastic syringes Appropriate Vacutainer collection tubes to draw a predetermined volume of blood (these may include serum separator tubes or and/or EDTA (anticoagulant) tubes, as required) Sterile disinfectant pads 9

10 Gloves providing barrier protection Tourniquets A disposal container for bio-hazardous waste A bio-hazard spill kit Adhesive bandage and gauze A cool-box Sealed Sample transport kits Secure transport bags and seals Transport temperature monitoring device All doping control documentation, including doping control forms, chain of custody forms, etc. 2. Sufficient sample collection equipment shall be made available to ensure that at all times an Athlete has a choice of at least three blood sample collection kits and two sample transport kits. 3. Any sample collection equipment systems used shall meet the following minimum criteria: Have a unique numbering system incorporated into all containers used to identify the Sample. Have a sealing system that is tamper-evident. Ensure the identity of the Athlete is not evident from the equipment itself. Ensure that all equipment is clean and sealed prior to use. D. The DCO should brief the BCO and any other collection personnel on their roles and responsibilities prior to or upon arrival at the collection site. E. The DCO should assess the collection site to ensure it meets the minimum requirements for blood sample collection. The site may be an Athlete s home or a hotel room, or other designated location, rather than an officially designated facility for doping control or blood collection, as long as it meets the minimum criteria. The minimum requirements to be met to enable use of a site as a blood collection facility are privacy and cleanliness. The requirements are necessarily more stringent than for a doping control station for the purpose of urine sample collection. If the facility does not meet the minimum requirements, the DCO may decide not to proceed with blood sample collection. The reasons for such a decision must be documented. F. If the Athlete is also providing a urine sample at the same session, the DCO may request that the Athlete provide the blood sample first. The Athlete shall be provided with the opportunity to hydrate. In order to ensure the same conditions for all, the Athlete shall remain seated and relaxed for at least 10 minutes before undergoing venipuncture. G. Before sample collection, the DCO should ask the Athlete whether they have been tested before, and whether they require an explanation of these blood sample collection procedures. If the Athlete has not been tested before, or requests an explanation of the procedure, the DCO and/or BCO should explain the blood sample collection procedure to the Athlete. 10

11 H. Conducting the Blood Sample Collection Session 1. Venipuncture: The type of equipment used for blood collection shall be the standard type required by prominent national and international anti-doping programs. 2. After the required rest period, and the DCO/BCO explanation of procedure, the DCO shall direct the Athlete to choose the blood sample collection kit(s), as required by VADA. It is recommended that there are at least three (3) blood sample collection kits from which to choose. The kit will typically include the sterile needle, syringe and the relevant vacutainer tubes packaged together in a sealed bag. If kits contain only one vacutainer, and an A and B sample are required, the Athlete shall choose two Blood Sample collection kits. 3. The Athlete and DCO/BCO shall check that the equipment is clean and intact. If either the Athlete or DCO/BCO is not satisfied with the equipment, the Athlete should make another selection. 4. If the Athlete is not satisfied with any of the equipment, and the DCO does not agree with the Athlete s opinion that all of the available equipment is unsatisfactory, the DCO shall instruct the Athlete to proceed with the sample collection session and the Athlete s views must be recorded on the doping control documentation by the DCO. 5. If both the DCO and the Athlete agree that none of the equipment is satisfactory, the DCO shall terminate sample collection, and record the reasons. 6. When the Blood Sample collection kit has been selected, the Athlete and the DCO shall proceed with the selection of the Sample transport kit. 7. If the secure transport kit includes pre-printed bar code labels, the Athlete shall remove these labels from the secure transport kit, and shall verify with the DCO that the code numbers match the transport kit numbers. 8. If the Athlete or DCO find that the numbers are not the same, the DCO shall instruct the Athlete to choose another secure transport kit, and shall document the occurrence. 9. The Athlete shall place one label longitudinally on each of the vacutainer tubes. The label shall be placed towards the top of the tube(s), near the cap. The Athlete may authorize the DCO or BCO to place the labels on the tubes. 10. The DCO shall record the numbers, and the Athlete and the DCO shall check the documentation to ensure that the DCO has accurately recorded the information. 11. The Athlete shall give the BCO the Blood Sample collection equipment, including the vacutainer(s). The BCO shall assemble the equipment in sight of the Athlete. 12. The BCO shall assess the most suitable arm for venipuncture. This will always be the non-dominant arm, unless the BCO assesses the other arm to be more suitable or the Athlete requests a specific arm. 13. If the BCO believes that a butterfly needle is required for venipuncture, the Athlete shall be asked to select a butterfly needle from a selection of sealed needles. The procedure then continues as normal. 14. If necessary, the BCO shall apply a tourniquet to the Athlete s upper arm. If the Athlete has a skin problem, the tourniquet shall be applied over thin clothing or a paper tissue so that the skin is not pinched. 11

12 15. The skin at the puncture site shall be cleaned with a sterile disinfectant wipe or swab. The needle shall be inspected visually before insertion. After the BCO has inserted the needle into the antecubital vein, the tourniquet shall be removed. 16. The BCO shall collect the amount of blood advised by VADA for the type of sample analysis to be conducted. The collection vessel(s) shall always be kept in full view of the Athlete. 17. In the event that the BCO is unable to draw sufficient blood from the first attempt, the procedure shall be repeated and up to three attempts in total shall be made before the DCO, in consultation with the BCO, decides to terminate collection. No more than three attempts to insert a needle into the Athlete s body shall be made. The DCO shall record the reasons for terminating the collection attempt. 18. The blood shall be collected into one or more vessels, depending on VADA s requirements for the particular analysis. (See also Section J, below, regarding post-collection processing.) 19. Blood collection equipment must be disposed of in accordance with the required standards for handling blood and the BCO s protocol. 20. If there is a temperature recording device available, it should be used to monitor the transport conditions to ensure temperature reaches 2-8 degrees Celsius before Samples are placed inside cool-box. Use of a temperature recording device is not necessary. I. Aftercare procedure 1. After withdrawing the needle from the Athlete s arm, the BCO shall place a pad over the puncture site and instruct the Athlete to press firmly on the pad. The BCO may also choose to apply pressure to the wound. 2. If necessary, pressure shall be applied for 2 3 minutes prior to undertaking the sample sealing procedure. The BCO shall assess the wound and indicate to the Athlete and the DCO when the Athlete is ready. 3. The BCO or the DCO shall advise the Athlete not to undertake any strenuous exercise using the arm for at least 30 minutes. This minimizes any potential bruising. 4. The BCO shall be prepared to conduct first-aid if necessary. J. Post-collection processing 1. For the analysis of whole blood or plasma, the 2 x 3mL blood samples, comprising of an A and a B sample should be inverted gently eight (8) to ten (10) times to mix the blood with the anti-coagulant contained in the tube in order to avoid clot formation. This step shall be taken as soon as possible. The blood samples then be sealed and made ready for transportation. 2. For the analysis of serum, the 2 x 5mL blood samples, comprising of an A and a B sample should be inverted gently five (5) times to initiate clotting and remain at room temperature for the time recommended by the tube manufacturer (15 minutes for BD Vacutainer SST II advance tubes) before being sealed and made ready for transportation. For Samples collected that require being left at room temperature for a pre-determined length of time (as specified by the tube manufacturer), the Athlete should be asked and encouraged to remain and observe his/her samples for this period of time. If 12

13 the Athlete declines to do so, this in no way invalidates the test. The DCO should maintain these Samples under their observation and monitor the predetermined period of time. The DCO will record details of any Athlete that does not remain to observe their Samples during this period. K. Sealing of the Blood Samples 1. The DCO shall instruct the Athlete to place one blood sample into each of the A and B sample transport kits. The Athlete may request the DCO to complete this process on their behalf. 2. Both the DCO and the Athlete shall check that the kits are securely sealed. Where possible, care must also be taken so that the samples are stored upright. 3. The DCO and Athlete should ensure that the equipment code numbers are accurately recorded on the doping control documentation. The Athlete and DCO should initial or sign the documentation to show they are satisfied with the procedure. 4. The DCO shall ensure the blood sample is stored in a secure, preferably cooled (2-12 degrees Celsius), location (i.e. transport bag) until ready to transport. L. Paperwork 1. The DCO shall instruct the BCO to sign the form to confirm that he/she collected a blood sample from the Athlete in accordance with procedures. 2. The Athlete shall be provided an opportunity to document any blood transfusions over the last six months, and to indicate any medications, including those which may affect the ability of the blood to clot, taken over the past seven days. 3. The DCO shall check all information on the form and sign to confirm that the blood sample collection was conducted in accordance with procedures. 4. The Athlete shall be invited to check that all information on the form accurately reflects the details of the sample collection session. The Athlete shall be invited to complete the comments section of the form if he/she has any concerns or comments regarding the procedure. If there is insufficient space on the form, the Athlete shall be invited to complete a supplementary report form. 5. The DCO, the Athlete Representative, if present, and the Athlete shall then sign the doping control form. 6. If there is a combined urine/blood doping control form: a. If the urine sample has already been collected, the DCO, the Athlete Representative, if present, and the Athlete shall sign the doping control form. b. If the urine sample has not yet been collected, the Athlete shall proceed to provide a urine sample before the DCO, the Athlete Representative, if present, and the Athlete shall sign the doping control form. 7. The DCO should give a full copy of the form to the Athlete, if available. M. Blood Sample Storage 1. The DCO is responsible for ensuring that all samples are stored in a manner that protects their identity, integrity and security. 13

14 2. Samples must not be left unattended, unless they are locked away, in a refrigerator or cupboard, for example. Access shall be restricted to authorized personnel. 3. The blood samples must be stored in a cool location, preferably in a refrigerator or cool box. Temperature should be maintained between 2 12 degrees Celsius. 4. If the conditions of storage did not meet the above guidelines for temperature, the DCO shall document this, and shall also contact VADA immediately to inform VADA of the variation in temperature, and the length of time the samples were affected. 5. If the temperature deviates outside the recommended 2-12 degrees for a period of time likely to affect the composition of a blood sample, VADA and the Laboratory shall determine whether or not analysis should proceed on the sample. 6. The DCO shall accurately complete appropriate documentation for each transport bag/container to ensure that the Laboratory can verify the contents of the bag/container. 7. The DCO shall follow VADA s instructions to ensure that analysis instructions (e.g. type of analysis to be conducted) are provided to the Laboratory. 8. The DCO shall complete the Laboratory advice form/chain of custody form. The Laboratory copy of this form and the Laboratory copy of the doping control form shall be placed in the transport bag with the samples. Documentation identifying the Athlete shall not be included with the samples. 9. If relevant, the DCO shall record the time(s) the transport bag is opened and closed, on the Laboratory advice form or chain of custody form. 10. The DCO shall keep the samples under his/her control until they are passed to the courier. Blood samples should be dispatched as soon as possible after collection to arrive at the Laboratory ideally on the same day, and preferably within hours of collection. 11. All documentation relevant to the testing session shall be forwarded to VADA as soon as possible after sample collection. VIII. Transport of Samples and Documentation A. Transportation of Urine Samples 1. Samples shall be shipped to the laboratory designated by VADA as soon as practical, and wherever possible on the day of collection. 2. Samples may be taken directly to the laboratory by the DCO, or handed over to a third party for transportation. This third party must document the chain of custody of the samples. If an approved courier company is used to transport the samples, the DCO should record the waybill number. 3. The laboratory designated by VADA is required to document receipt and the subsequent chain of custody of the samples. Samples are reviewed for evidence of tampering or damage, and stored in appropriate conditions. 4. All documentation relevant to the sample collection session should be forwarded to VADA by VADA s requested method as soon as possible after sample collection. 14

15 B. Transportation/handover of Blood Samples 1. Blood samples shall be transported to the designated laboratory in a refrigerated state. No sample should be allowed to freeze, and should ideally be kept at a temperature of approximately 4 degrees Celsius. Temperature should be maintained between 2 12 degrees Celsius. A temperature recording device may be included but is not required with the transported samples to ensure the appropriate temperature range has been maintained during transport. 2. Samples should remain in an upright position during transportation, whenever possible. 3. Samples may be taken directly to the laboratory by the DCO, or handed over to a third party for transportation. This third party must document the chain of custody of the samples. If an approved courier company is used to transport the samples, the DCO shall record the waybill number. 4. Due to the more stringent temperature and analysis requirements for blood, blood and urine samples may be transported separately. The relevant paperwork linking the two samples shall be included with each shipment, however. 5. Transport of blood sample(s) from site of collection to the designated laboratory should be made as soon as possible and preferably within 36 hours of collection. 6. The Laboratory is required to document receipt and the subsequent chain of custody of samples. Samples are reviewed for evidence of tampering or damage, and stored in appropriate conditions until analysis. IX. Modifications of these Procedures for Minors and Athletes with a Disability A. Minors or Athletes with specific types of disability may require modifications to these Sample collection procedures. Such modifications below do not affect the integrity of the Sample collection process. B. Athletes shall arrange with VADA in advance, where possible, modifications of these procedures. This may include the need for specialized sample collection equipment or special assistance during sample provision. C. The DCO shall have the authority to make modifications as the situation requires, in consultation with VADA where possible, as long as such modifications will not compromise the identity, security or integrity of the sample. Any modifications made to the standard Sample collection procedure shall be documented by the DCO. 15